FDA Outlines Cefaly Device Special Controls
About four months ago, the agency allowed it to be marketed as a preventative treatment for migraines.
The U.S. Food and Drug Administration has published a final rule listing the special controls that address the identified risks in using the Cefaly Device or similar devices. Approved in March 2014 by FDA to be marketed, the Cefaly Device is a patented, drug-free, battery-powered, prescription device that treats migraine pain with neurostimulation.
The FDA final order published July 3 says the special controls, in addition to general controls, "will provide reasonable assurance of the safety and effectiveness of this device." The special controls cover analysis and testing, labeling and warnings, software testing, and more. Any firm submitting a premarket notification for a transcutaneous electrical nerve stimulator to treat headaches will need to comply with them.
The Cefaly Device has been classified into class II, and FDA can exempt devices in that category from premarket notification requirements. But its order says for this type of device, FDA has determined premarket notification is necessary.